1. Field of the Invention
The present invention relates to vertebroplasty and a method and apparatus for strengthening vertebral bodies.
2. Description of the Prior Art
Percutaneous vertebroplasty is a technique involving the injection of a biomaterial into a vertebral body in order to treat the defects therein. It is performed using a set of surgical equipment assembled to complement such a procedure. For example, it is necessary to have equipment for prepping the patient's skin in order to provide antimicrobial effectiveness to the skin overlying the vertebrae. Equipment is also required to maintain the surgical area as clean and sterile as possible to help reduce the risk of infection. Equipment is further required to anaesthetize the patient to produce a reversible loss of sensation in the surgical area of the body, in preparation for incision. The incision is made by any suitable surgical equipment capable of cutting anatomical tissue. Also, it is necessary to have equipment with a sharp end able to penetrate the vertebral body for injection of the biomaterial into the vertebral body. Further, it is necessary to provide equipment for preparation of the biomaterial and delivery into the vertebral body.
Before a procedure can be performed, it is necessary to assemble all of the equipment that is likely to be needed for the procedure. Typically, the extent and complexity of the treatment is unknown prior to the procedure, that is, whether injections of biomaterial will occur into one, or both pedicles. Given this uncertainty, more equipment than necessary can be assembled to allow for a second injection. However, should the nature of the vertebral defect only require injections from one side of the vertebrae, then the unused biomaterial and equipment is wasted. Furthermore, after the equipment has been provided and arranged for use, it must be kept clean and sterile. Proper equipment sterilization is elementary before any procedure, to ensure complete elimination of microbial viability thus reducing risk of infection. If the equipment is laid out too far in advance of a procedure, the chances of maintaining sterility decreases. Contaminated or unused equipment is either replaced or discarded, thus making for a very time consuming and costly exercise. It is therefore desirable to assemble only the necessary equipment as close to the time of the procedure as possible.
There exists equipment for preparation and delivery of biomaterial into the vertebral body. For example, one of the more popular systems is a bone cement delivery system, available from Parallax-Medical, California, U.S.A. This reference is available at http://www.parallax-medical.com/products.html. This system contemplates that two injections will be needed in each procedure, thus the cement delivery system is pre-packaged to include pairs of equipment. However, this system is designed for any bone filling procedure and thus does not include all of the necessary components for percutaneous vertebroplasty.
Also disclosed is a commercially available set of equipment specifically designed for surgical procedures of the spine. It is contemplated that the equipment present in the kit not essential to the percutaneous vertebroplasty procedure will be unused. In sum, the present commercially available kits are not directed towards percutaneous vertebroplasty procedures, thus resulting in equipment being wasted. It would therefore be desirable to provide a set of sterilized equipment, packaged as a single unit, and containing all of the equipment necessary for performing only one injection in a percutaneous vertebroplasty procedure.